GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.
We are hiring for CQV Engineer for the Sligo region.
- Execute Commissioning and validation of manufacturing equipment, downstream equipment, and processes in addition to supervising and witnessing CQ carried out by vendors
- Develop protocols for validation projects using a risk-based approach that meets regulatory requirements and industry practices
- Lead Risk assessments for process and equipment as required.
- Promote cGMP and regulatory compliance into assigned projects
- Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning and Qualification protocols
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- CQV documentation – drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines.
- Accountable for scheduling, tracking, reporting, and achieving validation deadlines.
- Review and approve Layout development and review for material and personnel flow compliance
Education & Key Requirements
- Bachelor’s Degree in a related science or engineering discipline.
- 3-5 years plus experience process equipment C&Q/ Validation experience on Large Scale Projects.
- Excellent technical abilities, Problem solving skills, strong technical writing, and communication skills.
- Use of Delta V and associated new phase development and qualification works desirable.
- Promote a continuous improvement culture
- Excellent knowledge of relevant GMPs, regulations and current industry trends.